Ultrasonic Auricular Vagus Nerve Stimulator with Cannabinoid Coupling

This application is a nonprovisional conversion of and claims priority to U.S. Provisional Application 63/731,875 filed Jun. 18, 2024, the entirety of which is incorporated by reference herein.

This application is also a continuation-in-part of and claims priority to U.S. Nonprovisional application Ser. No. 18/631,192 filed Apr. 10, 2024, which is a nonprovisional conversion of U.S. Provisional Application No. 63/458,771 filed as a provisional patent application on Apr. 12, 2023, entitled “ULTRASONIC AURICULAR VAGUS NERVE STIMULATOR” and also a nonprovisional conversion of U.S. Provisional Application No. 63/577,988 filed as a provisional patent application on Jun. 12, 2023, entitled “DRIVE FOR ULTRASONIC AURICULAR VAGUS NERVE STIMULATOR”, the entirety of which are incorporated herein in their entirety.

The present disclosure relates generally to therapeutic stimulation using ultrasonic radiation and more particularly to ultrasound stimulation of the vagus nerve at the ear and coupling methods between ultrasonic transducers and a user.

In human anatomy, the vagus nerve is the tenth cranial nerve that relays sensory and motor information between the brain and organs in the chest and abdomen. The auricular branch of the vagus nerve lies within the tissue of both outer ears, as represented in the schematic view of, with representative portions of vagus nerve branches shown in enlarged the inset K. The vagus nerve V is considered part of the parasympathetic nervous system regulating and responding to conditions related to rest and digestion of the human user. Stimulation of the vagus nerve, such as electrical stimulation, is widely held to improve overall well-being of the user.

Vagus nerve stimulation has been approved by the Food and Drug Administration (FDA) to treat some forms of epilepsy, as well as depression. For some conventional methods of vagus nerve stimulation (VNS) treatment, healthcare providers implant a small electrical device in the chest, under the skin, to send mild, painless electrical signals through the left vagus nerve to the brain. These impulses can be shown helpful in calming irregular electrical activity in the brain.

There is accumulating evidence to suggest that vagus nerve stimulation can help to quell inflammation related to a number of other autonomic or inflammatory disorders, which would make it useful for a wide range of adult and pediatric patients.

In some early therapeutic work for neural stimulation, a set of conductive pads was attached to the body and a control mechanism to apply transdermal electrical shocks to a patient's limbs. A series of DC pulses can be applied to an area for a given period of time. In this sequence, a second time period with no stimulation passes, then a third interval of stimulation occurs, with reversed DC voltage. This process was shown to alleviate pain very rapidly.

Other earlier work discloses use of electrical shock to the auricular vagus nerve. In one embodiment, non-invasive electrodes are mounted on skin surfaces in the ear. One electrode is placed outside the ear conch and the second electrode is placed in the external auditory canal, implanted to excite the vagus nerve. A controller is connected to an electrical stimulation circuit and is adapted to provide vagus nerve stimulation. A feedback circuit based on physiological response can control the applied stimulation. The use of electrical shock, however, can be uncomfortable and can lead to neural scarring that reduces therapeutic value.

Still other work discloses modulating neural activity by using a reversible blocking condition of peripheral neural structures. The reversible blocking process is applied when the user is in a first state, and deactivated when the user is in a second state. External sensing components are used to detect neural activity and control the blocking energy. Certain embodiments disclose implanted sensors and antennae to sense and conduct therapeutic energy. Such types of apparatus can be applied over the surface of the extremities, including arms, legs, and fingers. However, the vagus nerve is embedded deeply into the neck, so that such a method can require surgical procedure in order to be reached with sufficient electrical signal.

In one earlier, non-invasive method of exciting the vagus nerve, the user presses a set of electrodes to the skin of the neck to provide electrostimulation of the Vagus nerves. The stimulation device interconnects with apparatus that records the therapy session. The information can be provided to medical personnel to monitor the therapeutic regime. The apparatus applies electrical energy in the form of an AC sinewave that is applied over periodic time intervals. However, contact pressure factors are not well-defined and providing sufficient electrical stimulation to stimulate the vagus nerve can be painful for the user.

More recent work has applied focused ultrasonic energy for peripheral nerve modulation. Ultrasound is used to locate a nerve within tissue. The nerve is then stimulated by focused ultrasound in order to modulate peripheral nerves, such as nerves in arms or legs. The ultrasound probe can use an imaging process to observe tissue deformation due to the focused ultrasound energy.

Another more recent apparatus is attached to the user's head for stimulating the auditory system. An ultrasound transmitter is held to the exterior of the head to focus ultrasound onto the cochlea, which is located deeply into the skull. An embodiment shows the device is located on the temple near the external ear canal and oriented to direct energy to the cochlea. Multiple transducers can be located on the headband for stimulation. In an embodiment, a plug is inserted into the ear canal and excited by a device housed behind the ear. The device within the ear canal emits ultrasonic radiation radially into the skull. The apparatus receives audible sound, translates that sound into one or more ultrasonic frequencies and directs the ultrasonic radiation at those frequencies to the cochlea to create a perception of sound to the user.

In yet other work, a garment supports a stimulating device for the user. The particular stimulation devices can include vibration or audible sound to effect positive therapy. The garment can cover the user's chest, abdomen, arms or legs. In one embodiment, an acoustic speaker is supported on a frame that directs sound energy towards the user head. Other embodiments disclose a single speaker located on the user's body. The stimulation devices are disclosed as providing acoustic, vibration, or electrical pulses delivered through contact with the skin. The stimulators are activated in response to external command from such sources as smart phone or computer games, for example.

Among other devices and configurations for stimulating the auricular vagus nerve, one approach uses a wearable neural stimulation device attached to the ear. The neural stimulator can use any type of energy, including mechanical, electrical, magnetic, ultrasound, optical, thermal or chemical energy. The supporting frame can support multiple stimulators in various areas of the ear. In one embodiment, the stimulation occurs in both ears through stimulators supported by a single frame. A member wraps around the back of the ear to secure the device to the ear and a neural stimulator operates in response to commands for a processor. The processor receives commands from a remote communication system. An audio speaker can be incorporated to provide audio information to the user.

Ultrasound therapy has been applied to muscle tissue to ease pain. An ultrasound transducer can provide mild heat and pulsed mechanical pressure to ease pain in muscles. The ultrasound transducer is typically coupled with an ultrasound fluid or gel to improve energy transmission to the afflicted tissue. The coupling gel is formulated to have physical properties similar to water. The coupling medium can be a gel, a thick, conductive substance that's typically made of water with a viscosity increasing agent, such as propylene glycol. Propylene glycol is a synthetic compound that's often found in food, cosmetics, and hygiene products. Other thickeners that may be found in ultrasound gel include glycerin, Carbomer, Sodium Hydroxide, Diazolidinyl Urea, Methylparaben, Disodium EDTA, Propylparaben coconut, and hemp fluid.

fluids are insoluble in water, but are soluble in fluids and solvent.fluids can be extracted from pulpedplants with heat or solvents. Ultrasound can also be used to extract cannabinoids from hemp directly, such as the Hielscher Ultrasonicator UP400St. The Ultrasonicator UP400St applies ultrasound to hemp in water to extract and separatefluids. The high intensity ultrasound coagulates and separates the fluid from the plant fiber and aqueous components of the hemp plant.

extracts have been found to be therapeutic when applied to and absorbed through the skin into the body.extracts can include various chemical structures, such as the CBDs and THCs. The various molecules in general have a calming effect. Various fluids or suspensions are commercially available that can be applied to areas of bodies to relieve tension. The extracts can be dispersedfluid particles in water orextracts in solution with a solvent agent.in such fluids can be in concentrations of between 5 and 35 percent. Nearly pure cannabinoids can also be used therapeutically.

It is well known that stimulation of the Vagus nerve can induce wellness. Stimulation of the Vagus nerve can occur in the auricular branch of the nerve using electrical stimulation, and our prior application discloses apparatus for stimulating the auricular branch of the vagus nerve using ultrasound. The ultrasonic therapy can be enhanced by the use of a coupling fluid between the transducer and the user's skin. Therapy can be further improved by the application of coupling fluid containing or consisting entirely of cannabinoids.

It is an object of the present disclosure to advance the art of stimulating the vagus nerve. Embodiments of the present disclosure provide non-invasive and readily usable vagus nerve stimulation with an apparatus that provides ultrasound energy to the auricular vagus nerve.

With this object in mind, the present disclosure provides a headset apparatus for a user to wear comprising:

(b) a coupling fluid on a surface of the ultrasound transducer that provides ultrasonic energy to pass into human skin and,

(c) a cannabinoid extract in solution with at least one coupling fluid.

In some cases, the coupling fluid is a solution that contains cannabidiol (CBD).

In addition the coupling fluid can be a solution that contains tetrahydrocannabinol (THC) with at least one carrier wherein the carrier is a coupling fluid, water, glycerine, and/or a combination of coupling fluid, water, glycerine and one or more emulsifiers.

Often, the coupling fluid is a solution that contains cannabinol as a terpene.

Here, the cannabinoid is in solution with at least a second component.

Often, the cannabinoid is in solution with one or more vegetable fluids.

Thecontaining fluid can be incorporated into a conformal pad.

It is possible for theconformal pad to be selectively removable from the apparatus.

In another embodiment, a method for using a headset apparatus adjustable for one or more users to wear comprises;

In some embodiments the coupling fluid is a solution that contains cannabidiol (CBD).

In yet another embodiment the coupling fluid is a solution that contains tetrahydrocannabinol (THC) with at least one carrier wherein the carrier is a coupling fluid, water, glycerine, and/or a combination of coupling fluid, water, glycerine and one or more emulsifiers.

The coupling fluid can also be a solution that contains cannabinol as a terpene.

In addition, the cannabinoid can be in solution with at least a second component.

Often the cannabinoid is found in solution with one or more vegetable oils/fluids.

In another embodiment thecontaining fluid is incorporated into a conformal pad.

Here, the user of theconformal pad can selectively remove the conformal pad from the headset apparatus.

These objects are given only by way of illustrative example, and such objects may be exemplary of one or more embodiments of the disclosure. Other desirable objectives and advantages inherently achieved by the disclosed disclosure may occur or become apparent to those skilled in the art. The invention is defined by the appended claims.

Figures provided herein are given in order to illustrate principles of operation and component relationships according to the present invention and may not be drawn with intent to show actual size or scale. Some exaggeration may be necessary in order to emphasize basic structural relationships or principles of operation. Some conventional components that would be needed for implementation of the described embodiments, such as support components used for providing power, for packaging, for interconnection, and for mounting, for example, may not be shown in the drawings in order to simplify description of the invention. In the drawings and text that follow, like components are designated with like reference numerals, and similar descriptions concerning components and arrangement or interaction of components already described may be omitted.

Where they are used, the terms “first”, “second”, and so on, do not necessarily denote any ordinal or priority relation, but may be used for more clearly distinguishing one element or time interval from another. The term “plurality” means at least two.

In the context of the present disclosure, the term “energizable” describes a component or device that is enabled to perform a function upon receiving power and, optionally, upon also receiving an enabling signal.

In the context of the present disclosure, positional terms such as “top” and “bottom”, “upward” and “downward”, and similar expressions are used descriptively, to differentiate different surfaces or views of an assembly or structure and do not describe any necessary orientation of the assembly in an apparatus. When used with respect to human anatomy, these terms relate to a user in normal standing or seated posture.

In the context of the present disclosure, the term “coupled” is intended to indicate a mechanical association, connection, relation, or linking, between two or more components, such that the disposition of one component affects the spatial disposition of a component to which it is coupled. For mechanical coupling, two components need not be in direct contact, but can be linked through one or more intermediary components.

The terminology “in signal communication” as used in the present application means that two or more devices and/or components are capable of communicating with each other via signals that travel over some type of signal path. Signal communication may be wired or wireless. The signals may be communication, power, data, or energy signals which may communicate information, power, and/or energy from a first device and/or component to a second device and/or component along a signal path between the first device and/or component and second device and/or component. The signal paths may include physical, electrical, magnetic, electromagnetic, optical, wired, and/or wireless connections between the first device and/or component and second device and/or component. The signal paths may also include additional devices and/or components between the first device and/or component and second device and/or component.

In the context of the present disclosure, the term “about” indicates that the value listed can be somewhat altered, as long as the alteration allows a component or assembly to be in reasonable conformance with the process or structure of the illustrated embodiment. The term “exemplary” is not intended to be limiting, but indicates an illustrative example, rather than implying an ideal.

In the context of the present disclosure, the term “ultrasound” refers to acoustic vibration frequencies above 20 KHz. In ultrasound stimulation, acoustic waves of mechanical energy are generated and used to apply pressure to nerve tissue. With tactile stimulation from ultrasound energy, the resulting pressure changes in intracellular and extracellular fluid appear to change cell membrane curvature and generate flexoelectric effects that propagate along the nerve tissue.

Research strongly suggests that pulsed pressure, with intervals of movement and rest, can be beneficial for allowing biochemical recovery during stimulation.

Referring to, the Applicant has found that the pinna P surface of the human ear can provide a useful access point for vagus nerve stimulation. Nerve portions of an auricular branch of the vagus nerve lie just under the pinna P surface of both ears, as shown in, and extend from there inward, toward other anatomy, including the brain. Some of the more accessible nerve fibers extending from the vagus nerve lie in the central depression of pinna P, the concha of the ear.

To provide a suitable device for stimulation of the vagus nerve at the pinna, wherein the device is suitable for consumer use, the Applicant as addressed a number of aspects that have not been met by any proposed solution, including:

In developing a hands-free apparatusto stimulate nerve endings using ultrasound energy, it is important to position the stimulus appropriately, so that the ultrasound signal is most effective. However, the Applicant has found that, for most users, ultrasound stimulation applied to the pinna P of the ear can be difficult or impossible for the wearing user S to perceive. That is, unlike apparatus that apply other forms of stimulating energy, ultrasound apparatus provides no clear-cut, intuitive clues for the user to ascertain and guide proper placement of the signal source of apparatusagainst the skin surface. For design of a wearable device, this means that the wearer can't be expected to adjust device positioning and alignment to achieve the best results. Moreover, in order for the ultrasound stimulation to be effective, sufficient nesting force F must be applied to urge the transducer firmly enough against the skin without causing discomfort. Otherwise, without proper position and nesting pressure, even when the ultrasound device is energized, the emitted signal may not be well-directed and therefore could be ineffective in providing therapeutic benefit.